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Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis

NCT04313400 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-05-02

Study results available
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Summary

This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates safety and efficacy of 1.1% w/w AMTX-100 CF versus placebo (vehicle).

The study has two parts:

Phase I (Part 1):

Approximately Twenty-five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF.

Phase II (Part 2):

Approximately sixty (60) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with 1.1% w/w AMTX-100 CF3 concentration or Vehicle (Placebo) in the study.

Conditions

Interventions

DRUG

1.1% w/w AMTX-100 CF-part1

AMTX-100 CF, topical cream with 1.1% w/w active pharmaceutical ingredient

DRUG

Placebo

Topical cream manufactured to mimic AMTX-100 CF3

DRUG

1.1% w/w AMTX-100 CF3-part2

AMTX-100 CF3, topical cream with 1.1% w/w active pharmaceutical ingredient

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Amytrx Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Arezou Bayat, MD, MPH · Amarex Clinical Research, LLC (Amarex)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2023-12-19
Completion
2024-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04313400 on ClinicalTrials.gov